HER2-positive Breast CancerPhase 2NCT07787338
SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy for Stage II-III HER2-Positive Breast Cancer
A Phase 2 study testing SHR-A1811 and THPy in people with HER2-positive Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a prospective, open-label, phase II, multicenter exploratory clinical study. Eligible female patients aged 18-75 years with stage II-III HER2-positive breast cancer will receive 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- SHR-A1811 and THPy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged ≥18 years and ≤75 years.
- Histopathologically confirmed invasive breast cancer with no prior systemic anti-tumor therapy for breast cancer.
- Histopathologically confirmed HER2-positive status in accordance with the 2018 ASCO-CAP HER2 testing guideline criteria: immunohistochemistry (IHC) score of 3+, or IHC 2+ with positive in situ hybridization (ISH) test (ISH amplification ratio ≥2.0); hormone receptor status must be available.
- Stage II-III breast cancer per the 8th edition AJCC Breast Cancer Staging System.
- At least one measurable target lesion according to RECIST Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate function of major organs as defined below (no blood transfusion, granulocyte-stimulating factors or thrombopoietic agents administered within 2 weeks prior to screening):
- Hematology: absolute neutrophil count (ANC) >1.5×10⁹/L; platelet count (PLT) >75×10⁹/L; hemoglobin (Hb) >90 g/L.
- Serum biochemistry: total bilirubin (TBIL) <1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <1.5×ULN; alkaline phosphatase <2.5×ULN; blood urea nitrogen (BUN)/urea and creatinine (Cr) <1.5×ULN.
- Echocardiogram: left ventricular ejection fraction (LVEF) ≥55%.
- 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) <470 msec.
- For premenopausal women of childbearing potential: serum or urine pregnancy test must be negative within 7 days before treatment initiation; not breastfeeding. All participants must use effective barrier contraception throughout treatment and for 6 months after completion of study treatment.
- Voluntarily provide written informed consent, demonstrate good compliance and willingness to complete scheduled visits and study-related procedures.
Who cannot join
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Prior anti-tumor therapy or radiotherapy for any malignancy, or concurrent other malignant tumors, except cured carcinoma in situ of cervix, basal cell carcinoma or squamous cell carcinoma.
- Concurrent receipt of anti-tumor therapy in another clinical trial, including but not limited to chemotherapy, endocrine therapy, biotherapy, bone-modifying agent therapy or immune checkpoint inhibitor therapy.
- Major surgery unrelated to breast cancer performed within 4 weeks prior to the first dose of study drug, or participants who have not fully recovered from such surgery.
- Severe cardiac disorders, including but not limited to:
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- Confirmed history of heart failure or systolic dysfunction (LVEF <50%).
- High-risk uncontrolled arrhythmias, such as atrial tachycardia with resting heart rate >100 bpm, significant ventricular arrhythmia (e.g., ventricular tachycardia), or advanced atrioventricular block (Mobitz type II second-degree or third-degree atrioventricular block).
- Angina requiring anti-anginal medication.
- Electrocardiogram evidence of transmural myocardial infarction.
- Poorly controlled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg) despite medical treatment.
- Uncontrolled active infection requiring treatment; history of immunodeficiency including positive HIV test, other acquired or congenital immunodeficiency disorders, or history of organ transplantation.
- Known hypersensitivity to any components of study drugs specified in this protocol.
- Pregnant or breastfeeding women; women of childbearing potential with positive baseline pregnancy test; women of childbearing potential unwilling to use effective contraception throughout the study and for 6 months after the last study drug administration.
- Known or suspected interstitial lung disease; moderate to severe pulmonary diseases that may interfere with detection or management of drug-related pulmonary toxicity and severely impair respiratory function within 3 months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease; any autoimmune, connective tissue or inflammatory diseases involving the lung such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis; or prior history of pneumonectomy.
- Severe concomitant illnesses or other comorbidities that would interfere with planned treatment, or any other conditions rendering the participant unsuitable for participation in the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Minya Yao, 13634111760, yminya@163.com
Peifen Fu
About this study
Official title: A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Efficacy and Safety of SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy in Stage II-III HER2-positive Breast Cancer
This is a prospective, open-label, phase II, multicenter exploratory clinical study. Eligible female patients aged 18-75 years with stage II-III HER2-positive breast cancer will receive 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). After 4 cycles, tumor response will be assessed per RECIST 1.1 criteria. Patients with a ≥50% reduction in tumor burden will continue with another 4 cycles of SHR-A1811 followed by definitive surgery. Patients with <50% reduction will receive 4 cycles of the THPy regimen (docetaxel + trastuzumab + pyrotinib) before surgery. Circulating tumor DNA (ctDNA) will be assessed for minimal residual disease (MRD) at baseline, after 4 cycles of treatment, and postoperatively. The primary endpoint is total pathological complete response (tpCR), assessed by an independent review committee (IRC). This study aims to evaluate the efficacy, safety, and feasibility of imaging- and MRD-guided neoadjuvant therapy in HER2-positive breast cancer.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- SHR-A1811, THPy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811, 4.8 mg/kg, intravenous infusion once every 3 weeks. All patients receive initial 4 cycles; responders continue additional 4 cycles before surgery.
THPyDrug
Combined regimen of docetaxel, trastuzumab, and pyrotinib. Administered for 4 cycles to patients with insufficient tumor response after the initial 4 cycles of SHR-A1811 prior to definitive surgery.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 with Response-Guided Therapy | Experimental | All participants receive an initial 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). After 4 cycles, tumor response is assessed per RECIST 1.1 criteria. Participants with ≥50% tumor regression continue with another 4 cycles of SHR-A1811, followed by definitive surgery. Participants with <50% regression switch to 4 cycles of the THPy regimen (docetaxel + trastuzumab + pyrotinib) before surgery. This is a single-arm, non-randomized, open-label, response-guided treatment strategy. Receives: Drug: SHR-A1811; Drug: THPy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of total pathological complete response (tpCR)
Measured: At the time of definitive surgery (approximately 24 weeks after enrollment)
Secondary outcomes (2)
Rate of breast pathological complete response (bpCR)
Measured: At the time of definitive surgery (approximately 24 weeks after enrollment)
Objective Response Rate (ORR)
Measured: After 2 cycles of study treatment (approximately 6 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787338
- Sponsor's protocol ID
- 26-OBU-ZJ-BC-II-020
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Efficacy and Safety of SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy in Stage II-III HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07787338
- Acronym / sponsor ID
- 26-OBU-ZJ-BC-II-020
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, phase II, multicenter exploratory clinical study. Eligible female patients aged 18-75 years with stage II-III HER2-positive breast cancer will receive 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). After 4 cycles, tumor response will be assessed per RECIST 1.1 criteria. Patients with a ≥50% reduction in tumor burden will continue with another 4 cycles of SHR-A1811 followed by definitive surgery. Patients with <50% reduction will receive 4 cycles of the THPy regimen (docetaxel + trastuzumab + pyrotinib) before surgery. Circulating tumor DNA (ctDNA) will be assessed for minimal residual disease (MRD) at baseline, after 4 cycles of treatment, and postoperatively. The primary endpoint is total pathological complete response (tpCR), assessed by an independent review committee (IRC). This study aims to evaluate the efficacy, safety, and feasibility of imaging- and MRD-guided neoadjuvant therapy in HER2-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 with Response-Guided Therapy | Experimental | Drug: SHR-A1811, Drug: THPyAll participants receive an initial 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). After 4 cycles, tumor response is assessed per RECIST 1.1 criteria. Participants with ≥50% tumor regression continue with another 4 cycles of SHR-A1811, followed by definitive surgery. Participants with <50% regression switch to 4 cycles of the THPy regimen (docetaxel + trastuzumab + pyrotinib) before surgery. This is a single-arm, non-randomized, open-label, response-guided treatment strategy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female aged ≥18 years and ≤75 years.
- Histopathologically confirmed invasive breast cancer with no prior systemic anti-tumor therapy for breast cancer.
- Histopathologically confirmed HER2-positive status in accordance with the 2018 ASCO-CAP HER2 testing guideline criteria: immunohistochemistry (IHC) score of 3+, or IHC 2+ with positive in situ hybridization (ISH) test (ISH amplification ratio ≥2.0); hormone receptor status must be available.
- Stage II-III breast cancer per the 8th edition AJCC Breast Cancer Staging System.
- At least one measurable target lesion according to RECIST Version 1.1.
Key exclusion criteria (16 listed)
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Prior anti-tumor therapy or radiotherapy for any malignancy, or concurrent other malignant tumors, except cured carcinoma in situ of cervix, basal cell carcinoma or squamous cell carcinoma.
- Concurrent receipt of anti-tumor therapy in another clinical trial, including but not limited to chemotherapy, endocrine therapy, biotherapy, bone-modifying agent therapy or immune checkpoint inhibitor therapy.
- Major surgery unrelated to breast cancer performed within 4 weeks prior to the first dose of study drug, or participants who have not fully recovered from such surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811SHR-A1811, 4.8 mg/kg, intravenous infusion once every 3 weeks. All patients receive initial 4 cycles; responders continue additional 4 cycles before surgery. | Drug | SHR-A1811 with Response-Guided Therapy |
| THPyCombined regimen of docetaxel, trastuzumab, and pyrotinib. Administered for 4 cycles to patients with insufficient tumor response after the initial 4 cycles of SHR-A1811 prior to definitive surgery. | Drug | SHR-A1811 with Response-Guided Therapy |
Primary outcome
Rate of total pathological complete response (tpCR)
Time frame: At the time of definitive surgery (approximately 24 weeks after enrollment)
2 secondary outcomes
Rate of breast pathological complete response (bpCR)
Time frame: At the time of definitive surgery (approximately 24 weeks after enrollment)
Objective Response Rate (ORR)
Time frame: After 2 cycles of study treatment (approximately 6 weeks after enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 and THPy in people with HER2-positive Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peifen Fu (0571-87236852, Fupeifen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of total pathological complete response (tpCR) (time frame: At the time of definitive surgery (approximately 24 weeks after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.